Related Experiment Video
Updated: Jan 22, 2026
Author Spotlight: Advancing Diabetes Research with Static Exercise Training in Mice
Published on: March 29, 2024
Hydroxychloroquine as an adjunct therapy in the management of type 2 diabetes in pregnancy: study protocol for a
Nurul Iftida Basri1,2, Norasyikin A Wahab3, Azmawati Mohammed Nawi4
1Obstetrics & Gynaecology, National University of Malaysia Faculty of Medicine, Federal Territory of Kuala Lumpur, Malaysia.
Introduction:
The increasing incidence of type 2 diabetes mellitus (T2DM) among women of reproductive age poses significant health risks for both mothers and their fetuses. Optimising blood glucose levels during pregnancy is particularly challenging, even with a combination of oral antidiabetic agents and insulin therapy. Hydroxychloroquine (HCQ) has been shown to lower glucose levels in non-pregnant populations and has demonstrated safety in pregnant women with systemic lupus erythematosus and rheumatoid diseases. In addition to its glucose-lowering effects, HCQ also exhibits immunomodulatory, antioxidant and anti-inflammatory properties. Given that both T2DM and pregnancy are pro-inflammatory states, inadequate glycaemic control may exacerbate adverse pregnancy outcomes. We hypothesise that adjunctive treatment with HCQ in this cohort could improve glycaemic control, reduce systemic inflammation and subsequently lower the risk of adverse pregnancy outcomes.
Methods And Analysis:
This is a prospective, open-label, randomised controlled trial involving 56 pregnant women diagnosed with T2DM. Participants will be randomly allocated, using computerised randomisation software, into either a control group receiving standard care or an intervention group receiving standard care with HCQ 200 mg daily. The primary outcomes will be the difference in glycaemic parameters and inflammatory markers. Secondary outcomes include the assessment of pregnancy outcomes between the groups, such as gestational age at delivery, postpartum haemorrhage, fetal macrosomia and shoulder dystocia.
Ethics And Dissemination:
This protocol has been approved by the National University of Malaysia Ethics Committee (JEP-2023-866). Study findings will be disseminated via presentations at academic conferences, publications in peer-reviewed journals and professional training and meetings to healthcare professionals.
Trial Registration Number:
This study was registered in ClinicalTrials.gov (NCT06319560) on 23 January 2024.
Related Concept Videos
01:22Diabetes Mellitus: Type 2 and Gestational
01:22Heart Failure VI: Adjunct Therapies
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:15Diabetes: Management and Pharmacotherapy
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
01:22Diabetes Mellitus: Overview and Type I Subtype
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
01:30Inflammatory Bowel Disease III: Diagnostic Studies and Management I-Nutritional Therapy
Diagnostic studies
A colonoscopy is the definitive screening test, distinguishing ulcerative colitis from other colon diseases with similar symptoms. During a colonoscopy test, inflamed mucosa with exudate ulcerations can be observed, and biopsies are taken to determine the histologic characteristics of the...